NCT04389450终止2 期
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
Pluristem Ltd.23 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 23
- 主要终点
- Number of ventilator free days
研究概览
简要总结
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
- •Male or non-pregnant female adult 40-80 years of age at time of enrollment.
- •Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
- •Meets definition of ARDS according to Berlin criteria.
排除标准
- •Body weight under 55 kg (121 lbs)
- •Serum creatinine level of over 1.5 mg/dL at time of randomization.
- •Total Bilirubin ≥2 mg/dL at time of randomization.
- •Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
- •Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
- •Chronic Obstructive Pulmonary disease GOLD stage above II.
结局指标
主要结局
Number of ventilator free days
时间窗: 28 days
次要结局
- All-cause mortality(28 days)
- Duration of mechanical ventilation(8 weeks)
研究者
研究点 (23)
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